MAUDE Adverse Event Report: UNKNOWN IV SCIG 36" 24G, 12MM; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Spontaneous.Patient reported leakage during hyqvia infusion with 12mm needle set.Per patient, she infuses with 2 needle sets and one needle set presented no problems.The other needle set caused leakage of approximately 50ml loss of medication.Per patient, her clothing was wet and she had to change multiple times.Per patient, pain at the injection site.Md unaware.No missed dose but pt only got partial dose; unknown if available for return; no further information provided.Strength: sgm/soml & 20gm/200ml.Reported to cvs/caremark by: patient/caregiver.

• Brand Name: IV SCIG 36" 24G, 12MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17551091
• MDR Text Key: 321285703
• Report Number: MW5144578
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: HYQVIA.
• Patient Sex: Female